With prolonged treatment, the adverse experience profile did not significantly change.The safety profile of SINGULAIR, when administered as a single dose for prevention of EIB in pediatric patients 6 years of age and older, was consistent with the safety profile previously described for SINGULAIR.In studies evaluating growth rate, the safety profile in these pediatric patients was consistent with the safety profile previously described for SINGULAIR. Regular monitoring of liver function tests is necessary while receiving this medicine. The pharmacokinetic profile and the oral bioavailability of a single 10-mg oral dose of montelukast are similar in elderly and younger adults. SINGULAIR is used to:1. In studies with therapeutic doses, plasma concentrations of metabolites of montelukast are undetectable at steady state in adults and pediatric patients.In vitro studies using human liver microsomes indicate that CYP3A4, 2C8, and 2C9 are involved in the metabolism of montelukast. Growth rates, expressed as least-squares (LS) mean (95% CI) in cm/year, for the SINGULAIR, placebo, and beclomethasone treatment groups were 5.67 (5.46, 5.88), 5.64 (5.42, 5.86), and 4.86 (4.64, 5.08), respectively.

How it works . Safety and efficacy in patients younger than 6 years of age have not been established. Some medicines may … We’ve made all possible efforts to ensure that the information provided here is accurate, up-to-date and complete, however, it should not be treated as a substitute for professional medical advice, diagnosis or treatment. Both chewable tablets contain the following inactive ingredients: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, red ferric oxide, croscarmellose sodium, cherry flavor, aspartame, and magnesium stearate. This medicine can be taken with or without food. The estimated difference between SINGULAIR and placebo was -0.04 with a 95% CI of (-0.09, 0.01). EliminationThe plasma clearance of montelukast averages 45 mL/min in healthy adults. These medications included Phenobarbital, which induces hepatic metabolism, decreased the area under the plasma concentration curve (AUC) of montelukast approximately 40% following a single 10-mg dose of montelukast. Montelukast at doses of ≥100 mg daily dosed to pharmacokinetic steady state did not significantly alter the plasma concentrations of either component of an oral contraceptive containing norethindrone 1 mg/ethinyl estradiol 35 mcg. The packet should not be opened until ready to use. … Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. The incidence of somnolence was similar to that of placebo.The safety in patients 2 to 14 years of age with perennial allergic rhinitis is supported by the safety in patients 2 to 14 years of age with seasonal allergic rhinitis. Exacerbates Montelukast. You may report side effects to FDA at 1-800-FDA-1088.Montelukast sodium, the active ingredient in SINGULAIR, is a selective and orally active Montelukast sodium is described chemically as [R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt.Montelukast sodium is a hygroscopic, optically active, white to off-white powder. Practo does not assume any responsibility for any aspect of healthcare administered with the aid of information provided above. Prevent asthma attacks and for the long-term treatment of asthma in adults and children ages 12 months and older. Patients already taking SINGULAIR daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB.

Singulair montelukast is a leukotriene loo-koe-TRY-een inhibitor. For pediatric patients 2 to 5 years of age: one 4mg chewable tablet or one packet of 4- mg oral - granules. The estimated exposure in rats was approximately and 75 times the AUC for … All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.